Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks

NCT ID: NCT04052347

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2020-12-01

Brief Summary

The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks

Conditions

Pregnancy Related; Elective Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Shared decision-making with a patient decision-aid

Group Type: EXPERIMENTAL

Shared decision-making with a Decision-aid

Intervention Type: BEHAVIORAL

A tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9

routine shared decision-making

control group

Group Type: ACTIVE_COMPARATOR

routine shared decision-making

Intervention Type: BEHAVIORAL

control group

Interventions

Shared decision-making with a Decision-aid

A tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9

Intervention Type: BEHAVIORAL

routine shared decision-making

control group

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Low-risk nulliparous women- no previous pregnancy > 23 weeks
• 18-50 years of age
• Singleton gestation
• Between 34.0 and 36.6 weeks at the time of screening. Randomization must occur between 37.0-37.6 weeks inclusive.

Exclusion Criteria

• 1. First sonographic examination after 20 weeks 2. Women with any of the following comorbidities (at the time of randomization):

1. Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)

2. Cerclage in the index pregnancy

3. Diabetes mellitus-gestational or pre-gestational

4. Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)

5. Hypertension (chronic or pregnancy induced) before enrollment

6. HIV (human immunodeficiency virus)

7. Institutionalized individuals (prisoners)

8. Prior obstetric history of: 1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia, eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death

9. Preterm labor or ruptured membranes before enrollment

10. Psychiatric disorder (bipolar, depression) on medication

11. Placenta previa / 3rd trimester bleeding

12. Renal insufficiency (serum creatinine > 1.5 mg/dL)

13. Restrictive lung disease

14. Fetal red blood cell isoimmunization

15. Seizure disorder on medication

16. Thyroid disease on medication

17. Body Mass Index (BMI) above 40 kg/m 3. Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects 4. Unable to understand consent in English or Spanish

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Sunbola S Ashimi Ademola

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-19-0490

Identifier Type: -

Identifier Source: org_study_id